Lipid Kinetics of Patients With Pneumonia

March 10, 2024 updated by: Omur ILBAN, Konya Numune Hospital

Lipid Kinetics of Patients With Nonfermenting Gram-Negative Bacterial Ventilator-Associated Pneumonia

Nonfermenting Gram-Negative Bacilli (NFGNB) are aerobic, non-motile, non-lactose fermenting, oxidase-negative, catalase-positive coccobacilli that pose a serious threat to critically ill patients. Primarily Pseudomonas aeruginosa (PA) and Acinetobacter baumannii (AB), are NFGNB which are potential multi-drug resistant (MDR) pathogens that are related to ventilator-associated pneumonia (VAP). In Nonfermenting Gram-Negative Bacilli (NFGNB) infections, which are potential multi-drug resistant (MDR) pathogens, pathogenesis is determined not only by bacterial virulence factors but more importantly by the interaction between bacteria and the host immune system. Thanks to their direct immunomodulatory properties, lipoproteins and lipids bind and neutralise toxic bacterial substances. During the acute phase response and inflammation, HDL presents significant structural and functional changes. This study was planned to evaluate the relationship between the changes of the serum lipid metabolism and other inflammation markers with the antimicrobial resistance status and the results in NFGNB VAP patients. Also, we aimed to investigate whether there is a difference in the clinical characteristics of the patients depending on the resistance profile of NFGNB.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

This prospective study was performed in adult intensive care unit (ICU) patients. They were intubated endotracheally and received mechanical ventilation (MV) treatment for at least 48 hours in Konya Numune Hospital ICU, which has 42 surgery and medicine beds. The study was conducted between May 2019 and December 2020 and approved by the Ethics Committee of Necmettin Erbakan University Medical School. Informed consents were obtained from the patients who participated in the study or from their relatives. The characteristics of the patients and the sequential changes of the inflammatory response including the lipid profile were recorded.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
131

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Konya, Turkey, 42060
        • Konya Numune Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The patients who were intubated endotracheally and received mechanical ventilation treatment for at least 48 hours in ICU.

Description

Inclusion Criteria:

  • ICU Patients of 18 years of age and above, with clinical suspicion of VAP as defined in the American Thoracic Society (ATS) guidelines and a simplified version of Clinical Pulmonary Infection Score (CPIS)> 6, with significant NFGNB growth in respiratory cultures and with no signs and symptoms of infection at the time of admission, were included in the study.

Exclusion Criteria:

  • Patients with chronic inflammatory disease, hepatic dysfunction, active tuberculosis, malignancy, malnutrition, severe immunosuppression (i.e., neutropenia, HIV positive, organ transplant, having received immunosuppressants or used ≥ 20 mg/day prednisone for two or more weeks in the preceding three months), those that within 72 hours since being included in the study had any extrapulmonary infection other than VAP, as well as those whose respiratory cultures presented bacterial agents other than NFGNB and fungal agents were not included in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Multi-drug resistant group (MDR)
Patients with resistant NFGNB isolate as MDR group
Non-Multi-drug resistant group (Non-MDR)
Patients with sensitive NFGNB isolate as Non-MDR group
Control group (Control)
Patients without suspicion of VAP and other signs of nosocomial infection as the control group

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum lipid metabolism
Time Frame: 18 months
The relationship between the changes of the serum lipid metabolism including total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and triglycerides with the antimicrobial resistance status and the results in NFGNB VAP patients
18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Clinical outcome
Time Frame: 18 months
The secondary outcome were the 30-day mortality rate of the patients depending on the resistance profile of NFGNB
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Konya Numune Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Omur ILBAN, MD, Konya Numune Hospital, Department of Intensive Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • omurilban

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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